Octreotide Compared With Loperamide Hydrochloride for Chemotherapy-Related Diarrhea in Patients With Colorectal Cancer

This study has been completed.
Sponsor:
Collaborators:
Southwest Oncology Group
Cancer and Leukemia Group B
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003057
First received: November 1, 1999
Last updated: May 9, 2009
Last verified: January 2009
  Purpose

RATIONALE: Drugs such as octreotide and loperamide hydrochloride use different ways to relieve the diarrhea caused by chemotherapy.

PURPOSE: Randomized phase III trial to compare the effectiveness of octreotide with loperamide hydrochloride for the treatment of chemotherapy-related diarrhea in patients who have colorectal cancer.


Condition Intervention Phase
Colorectal Cancer
Diarrhea
Drug: loperamide hydrochloride
Drug: octreotide acetate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Supportive Care
Official Title: Randomized Trial of High-Dose Versus Conventional Dose Octreotide Acetate Versus Loperamide in the Treatment of Chemotherpay-Related Diarrhea in Patients With Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 500
Study Start Date: November 1996
Primary Completion Date: May 2000 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Determine the safety and efficacy of octreotide acetate versus conventional therapy with loperamide hydrochloride for chemotherapy related diarrhea in patients with advanced colorectal malignancies undergoing chemotherapy with fluorouracil or fluorouracil based regimens.

OUTLINE: This is a prospective, randomized, parallel, open label, multicenter study. Patients are stratified by therapy, grade of diarrhea, and prior use of loperamide hydrochloride or octreotide acetate. Patients undergo 1 of 3 treatments. Patients receive either low doses of octreotide (arm A) or high doses of octreotide (arm B) subcutaneously 3 times daily for 5 days. Patients in arm C receive oral doses of loperamide following each unformed stool for 5 days. A diary is completed by patients to record medications and bowel history. Treatment continues if diarrhea persists beyond day 5, but will be considered a treatment failure. If diarrhea continues to worsen, patients are removed from study. All patients are followed for 24 days.

PROJECTED ACCRUAL: This study will accrue a total of 500 patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed colorectal carcinoma At least grade 2 diarrhea as a consequence of chemotherapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Concurrent enrollment into SWOG-9420 protocol allowed No sensitivity to octreotide acetate or loperamide hydrochloride Eligible if less than 24 hours since prior loperamide or octreotide and no resolution of diarrhea Not pregnant or lactating Effective contraception required of fertile patients Not HIV positive No idiopathic ulcerative colitis or Crohn's disease, acute stool culture positive bacterial colitis, pseudomembranous colitis, short bowel syndrome, enteroenteric fistulae, chronic pancreatitis, ischemic bowel disease, or gastrointestinal disorders known to cause diarrhea Absence of definitive culture results required

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior chemotherapy with a fluoropyrimidine alone or in combination with an accepted modulating agent (leucovorin, levamisole, methotrexate, interferon, PALA, or hydroxyurea) required Prior chemotherapy with uracil mustard and tegafur (UFT) allowed No concurrent chemotherapy allowed during study Endocrine therapy: Not specified Radiotherapy: No whole pelvic or abdominal radiation therapy allowed Surgery: No colectomy, coloanal anastamosis, abdominoperineal resection, or colostomy allowed Other: No antidiarrheal agents (e.g., diphenoxylate hydrochloride, elixir paregoric, opium tincture or tincture of belladonna, or kaolin) during study No cyclosporine allowed

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003057

  Show 33 Study Locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Southwest Oncology Group
Cancer and Leukemia Group B
Investigators
Study Chair: Scott Wadler, MD Albert Einstein College of Medicine of Yeshiva University
Study Chair: Mace L. Rothenberg, MD, FACP Vanderbilt-Ingram Cancer Center
Study Chair: Bhoomi Mehrotra, MD Long Island Jewish Medical Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003057     History of Changes
Other Study ID Numbers: CDR0000065713, E-E1295, CLB-9770, SWOG-E1295, NCI-P97-0081
Study First Received: November 1, 1999
Last Updated: May 9, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
colon cancer
rectal cancer
diarrhea

Additional relevant MeSH terms:
Colorectal Neoplasms
Diarrhea
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Loperamide
Antidiarrheals
Octreotide
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 18, 2014